Siemens C Reactive Protein Assay Recalled for Software Flagging Error
Siemens is recalling the Atellica CH C Reactive Protein assay due to incorrect software flagging that may cause erroneous test results. All lot numbers are affected and the product was distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a software flagging defect in a diagnostic assay. Per the severity rubric, the issue represents a risk-of-harm situation where potential injury has not been reported, consistent with Score 3 (High). The classification remains below Score 4 because no illnesses or injuries are documented.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica CH Revised C Reactive Protein (RCRP) assay, an automated laboratory diagnostic test used to measure C-reactive protein levels in clinical settings. The product is identified by Siemens Material Number 11537223 and UDI-DI 00630414610887.
The FDA determined that incorrect software flagging may occur during testing with this assay, potentially causing erroneous test results. This issue affects all lot numbers of the product.
The assay has been distributed nationwide in the United States and to more than 50 countries worldwide, including Australia, Brazil, Canada, China, Germany, India, Korea, and the United Kingdom, among others.
The recalled product
- Product
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- software-error
- incorrect-result
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number (SMN): 11537223
- UDI-DI: 00630414610887
- Lot numbers: All lots.
Distribution
Distributed nationwide across the United States.
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